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Immunomodulation Therapy + Radiation for Metastatic Breast Cancer
Study Summary
This trial is testing a new immunotherapy treatment for breast cancer that has spread to other parts of the body. The treatment uses a combination of drugs and radiation therapy to kill tumor cells and stimulate the immune system.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I'm sorry, it seems like the sentence got cut off. It looks like the criterion is incomplete. Can you please provide the full criterion so that I can help you rewrite it in plain language?My cancer was caused by previous radiation therapy.I am not currently on targeted cancer treatments except for hormone therapy.I have had immunotherapy directly into a tumor before.My heart condition severely limits my daily activities.I am willing to have a biopsy of my lesion.I do not have recent brain metastases treated with radiation within the last 4 weeks.I have not had any other cancer requiring systemic treatment in the last 3 years.I have severe breathing issues that aren't helped by draining fluid from around my lungs.I have had a lung condition like pneumonitis but it didn't require treatment.I need radiation therapy for symptom relief or to control the cancer, as advised by my oncologist.My tumor is in the breast, skin, or lymph nodes, measures 2-7 cm, and can be safely injected.My organs and bone marrow are functioning well.I have not had a heart attack or severe heart issue in the last 3 months.I have had acute myeloid leukemia or FLT3 genetic changes.My cancer is advanced and cannot be surgically removed, with no cure available.I had radiation under 68 Gy on the same area over 6 months ago.I have not received any live vaccines in the last 30 days.My cancer has worsened despite previous treatments.I have inflammatory breast cancer or uveal melanoma.I agree to receive injections of CDX-301, CDX-1140, and poly-ICLC.I have been diagnosed with HIV.I agree to undergo radiation therapy on my tumor.You currently have active hepatitis B or C.The spread of the disease must be measured according to specific criteria.I have had a stroke, TIA, DVT, or PE in the past year.I am currently taking blood thinners at treatment doses.I haven't taken any immune-weakening medicines, except inhaled steroids, for the last 3 weeks.My breast cancer is HER2 positive.I haven't had targeted therapy, chemo, radiation, or immunotherapy in the last 3 weeks.You currently abuse drugs or alcohol, or have a mental health condition that might make it hard for you to complete the treatment or follow-up. Testing for this is not always needed, but might be done if the doctor thinks it's necessary.My doctor thinks I'm not fit for the study drug due to my severe liver or lung condition.My bilirubin levels are rising quickly without liver or bile duct issues.I agree to use effective birth control or abstain from sex during the study.My injection site is healthy and not in an area affected by previous surgeries.You have a current or past autoimmune disease, or have had an organ transplant.I am fully active or can carry out light work.You have been diagnosed with major depression. Other stable mood disorders may be allowed after talking with the main doctor in charge of the study.
- Group 1: Cohort A (immunomodulators, radiation therapy)
- Group 2: Cohort B (immunomodulators, radiation therapy)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the typical purpose of administering Anti-CD40 Agonist Monoclonal Antibody CDX-1140?
"Combatting amino acid deficiency, dry eyes, and a decreased appetite can all be achieved by employing Anti-CD40 Agonist Monoclonal Antibody CDX-1140."
Is this clinical trial a unprecedented endeavor?
"Since the first clinical trial in 2007, sponsored by Baxter Healthcare Corporation and involving 4640 participants, Anti-CD40 Agonist Monoclonal Antibody CDX-1140 has been studied extensively. After obtaining Phase 4 drug approval, 13 studies were conducted across 8 nations and 34 cities."
To what extent is the population being studied in this medical experiment?
"Currently, this trial is not in need of participants. The initial posting for the study was on December 12th 2022 and it was last updated on November 14th 2022. For those searching for other studies related to breast cancer, 5203 clinical trials are actively seeking subjects while 13 trails involving Anti-CD40 Agonist Monoclonal Antibody CDX-1140 remain open at present."
What findings have been reported from prior investigations of Anti-CD40 Agonist Monoclonal Antibody CDX-1140?
"Presently, there are 13 ongoing clinical trials investigating Anti-CD40 Agonist Monoclonal Antibody CDX-1140. One of those trails has reached Phase 3 status. This drug is predominantly being studied in Los Angeles, California; however, 55 distinct medical centres have active studies for the treatment."
To what extent can Anti-CD40 Agonist Monoclonal Antibody CDX-1140 be detrimental to human health?
"The safety of Anti-CD40 Agonist Monoclonal Antibody CDX-1140 has been conservatively rated at 1 due to the limited evidence collected during its Phase 1 clinical trial."
What is the intended outcome of this research endeavor?
"This study, to be assessed over a 30-day period, will measure the occurrence of adverse events. Other objectives include analysing changes in infiltrating myeloid cell subsets such as dendritic cells (DCs), macrophages and monocytes; PD-L1 expression within neoplastic and nonneoplastic stromal elements of the tumor microenvironment; and alterations to immune biomarkers from baseline until completion of therapy. The collected data on these parameters is expected to facilitate graphic representation using dot plots alongside means and standard errors for both overall sample sizes as well as individual treatment arms at various time points."
Are new volunteers being recruited for this scientific trial?
"As of November 14th 2022, this clinical trial is not accepting any further candidates. Initially posted on December 12th 2022, the study has been closed off to new patients. However, there are still 5216 other medical trials open and actively recruiting subjects."
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